Sandoz Inc, a Novartis company, announced it began commercially shipping its version of generic Levothyroxine sodium tablets, a company release said. On June 23, 2004, the US FDA had approved the Sandoz Levothyroxine Sodium tablets as AB-rated (bioequivalent) to both Synthroid and Levoxyl.
Levothyroxine is indicated for the treatment of hypothyroidism. The Sandoz tablets are manufactured in all 12 dosage strengths -25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 mcg. Sandoz becomes the first generic pharmaceutical company to launch AB-rated versions of Synthroid and Levoxyl with an approval for all dosage strengths.
John Sedor, president and CEO of Sandoz North America, stated, "We are extremely pleased to launch our version of Levothyroxine sodium tablets. This product is fully substitutable for Synthroid and Levoxyl. Patients deserve a lower cost alternative in their treatment for hypothyroidism. Additionally, our product maintains 25-months of expiration dating. This longer expiration dating is excellent news for our customers and patients as it ensures greater product availability when needed," he added.
Sandoz Levothyroxine Sodium tablets were developed through a partnership between Sandoz Inc and MOVA Pharmaceutical Corporation, who will manufacture this product for Sandoz. Sales of Synthroid for 2003 were $818M and sales of Levoxyl for 2003 were $256M, according to IMS data.
Hypothyroidism is a condition whereby the thyroid gland fails to produce enough thyroid hormone. According to the American Association of Clinical Endocrinologists, an estimated 13 million Americans have thyroid disorders, with more than half undiagnosed.